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U.S. Department of Health and Human Services

Class 2 Device Recall Rely X

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  Class 2 Device Recall Rely X see related information
Date Initiated by Firm February 12, 2007
Date Posted May 11, 2007
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-0800-2007
Recall Event ID 37635
510(K)Number K991961  
Product Classification Dental Cement - Product Code EBF
Product 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.
Code Information 7CG code on syringe (Lot 20070124 on box/bag)
Recalling Firm/
Manufacturer		 3M Espe Dental Products
2111 Mcgaw Ave
Irvine CA 92614-0908
Manufacturer Reason
for Recall		 Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.
FDA Determined
Cause 2		 Other
Action All consignees including distributors were notified of the recall via telephone or mail on 2/27/2007. Communication with distributors included the product being recalled, the problem , recommended stop usage or distribution and directions for return shippment. Further, the consignees were also sent a letter which described the product and problem and what to do if the product was still availabe or had been used.
Quantity in Commerce 99
Distribution Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EBF and Original Applicant = 3M COMPANY
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